Oncology Clinical Data Specialist I

General Summary/Overview Statement: The Clinical Research Data Specialist I (CRDS I) works under general supervision to extract clinical data and research data from electronic medical records and other sources and enters this data into electronic data capture system utilized for the clinical research protocol. The CRDS I will be responsible for entering data for multiple oncology clinical trials. The CRDS I will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of data abstraction and data entry. This position does not include any direct patient contact. Principal Duties and Responsibilities: The CRDS I will perform the following responsibilities under general supervision by the Clinical Research Manager:

• Proactively track assigned research subject's upcoming protocol appointments and visits and document on central clinical research data specialist (CRDSP) tracker
• Effectively monitor research subject condition and take appropriate action to ensure compliance with research protocol data entry requirements
• Proactively take steps to obtain missing source documents from all relevant sources
• Identify inaccurate source documents and track source document inconsistencies until resolved.
• Ensure accurate and timely entry of required data into various study-specific electronic data-capture systems.
• Ensure appropriate documentation of own study-specific delegation and training prior to entering data.
• Ensure adequate source documentation is in place prior to entering data.
• Obtain and abstract complex clinical information from multiple sources (medical records, research records, etc.) for research subjects.
• Independently manage adverse event (AE) and concomitant medication (CM) data as required by the sponsor, institution, and federal regulations
• Independently manage tumor response data entry
• Enter vital signs and EKGs into study-specific electronic data-capture system independently as required for individual studies
• Enter quality of life assessments into study-specific electronic data-capture system independently as required for individual studies
• Enter all required correlative research blood samples and clinical safety laboratory specimen results into study-specific electronic data-capture system independently as required for individual studies
• Enter all protocol required tests and procedures independently into study-specific electronic data-capture system as required for individual studies
• Work professionally with sponsor representatives to review and correct data recorded in the case report forms.
• Track and appropriately manage sponsor data entry deadlines
• Resolve and answer data queries with minimal errors.
• Perform standard data management quality control steps.
• Maintain awareness of details of clinical data to identify missing or inaccurate data; and track data inconsistencies for team to review and report accordingly.
• Remain flexible and adapt to change and variety on the job.
• Effectively handle unexpected situations and changing research subject and protocol conditions
• Develop individual research visit flow charts, intake sheets, and other tools as needed to independently ensure timely and accurate data entry

Skills/Abilities/Competencies Required

• Careful attention to detail
• Good organizational skills
• Ability to follow directions
• Good communication skills
• Computer literacy
• Working knowledge of clinical research protocols
• Ability to demonstrate respect and professionalism for subjects' rights and individual needs

Education Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Research Related Experience 1-2 years preferred Knowledge, Skills and Abilities

• Attention to detail.
• Ability to recognize compliance and data integrity issues and respond appropriately.
• Working knowledge of clinical research protocols.
• Ability to communicate effectively with patients, vendors, contract research organizations and professional staff.
• Effective interpersonal and communication skills.

Physical Requirements Standing Frequently (34-66%) Walking Frequently (34-66%) Sitting Occasionally (3-33%) Lifting Frequently (34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-66%) 20lbs - 35lbs Pushing Occasionally (3-33%) Pulling Occasionally (3-33%) Climbing Rarely (Less than 2%) Balancing Frequently (34-66%) Stooping Occasionally (3-33%) Kneeling Occasionally (3-33%) Crouching Occasionally (3-33%) Crawling Rarely (Less than 2%) Reaching Frequently (34-66%) Gross Manipulation (Handling) Frequently (34-66%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%) Mass General Brigham Incorporated is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. #J-18808-Ljbffr Mass General Brigham (Enterprise Services)